Abraxane Wins Orphan Drug Designation

5 November 2009 (Last Updated November 5th, 2009 18:30)

The US Food and Drug Administration (FDA) has granted orphan drug status to Abraxane, to support development of the treatment to fight pancreatic cancer as well as stage IIB-IV melanoma. The Office of Orphan Products Development of the FDA granted orphan drug designation to Abraxane, de

The US Food and Drug Administration (FDA) has granted orphan drug status to Abraxane, to support development of the treatment to fight pancreatic cancer as well as stage IIB-IV melanoma.

The Office of Orphan Products Development of the FDA granted orphan drug designation to Abraxane, developed by Abraxis BioScience, as a chemotherapy agent Injectable Suspension (paclitaxel protein-bound particles for injectable suspension).

Orphan drug designation is granted to support the development of new treatments for rare and difficult diseases for which there is a small market.

Abraxis BioScience president and chief executive officer Lonnie Moulder said that the company was looking forward to the potential of bringing a new treatment option to patients with these difficult-to-treat cancers.

Enrollment is at Phase III of a study to evaluate Abraxane as a first-line therapy for advanced metastatic pancreatic cancer. A Phase III registration study comparing ABRAXANE to dacarbazine in stage IV chemotherapy naïve melanoma patients is also actively enrolling.